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HypotensionNCT02984956

Pleth Variability Index and Hypotension

An observational study of Hypotension and Pleth Variability Index, run by Erzincan University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Correct assessment of a patient's volume status is the most important goal for an anesthetist. However, most of the variables used for fluid response evaluation are invasive and technically challenging.Pulse oximeter is a non-invasive, standardized and widely used monitoring method in many countries. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Hypotension, Pleth Variability Index
What is being tested?
pleth variability index
Type of treatment
Medical device
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
Dec 2016to Nov 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients who underwent spinal anesthesia for hip fracture

Who may be able to join

  • over 65 years old
  • Patients to undergo spinal anesthesia

Who cannot join

  • Patients under 65 years old
  • Patients to undergo general anesthesia or only sedation
  • Patients with cardiac arrhythmia
  • Patients with low ventricular ejection fraction
  • Heart valve disease patients

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Erzincan University

    Erzincan

Other trials in Turkey (Türkiye)

About this study

Official title: Hypotension Relationship With Pleth Variability Index In Hip Fracture Patients Who Underwent Spinal Anesthesia

Correct assessment of a patient's volume status is the most important goal for an anesthetist. However, most of the variables used for fluid response evaluation are invasive and technically challenging.Pulse oximeter is a non-invasive, standardized and widely used monitoring method in many countries. Our aim in this study is to investigate the usefulness of the noninvasive pleth variability index to predict hypotension in orthopedic hip fracture patients who underwent spinal anesthesia.

Being tested
pleth variability index
Keywords
Hypotension, Pleth variability index, Hip Fracture, Spinal anesthesia
Medical subject headings
Hypotension, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pleth variability indexDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detecting pleth variability index-hypotension relationship

    Measured: one year

Secondary outcomes (3)

  1. pleth variability index response to fluid management

    Measured: one year

  2. Make a differential diagnosis of hypotension with pleth variability index

    Measured: one year

  3. Correlation between arterial hemoglobin and pleth variability index hemoglobin

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionOct 2017 (estimated)
  4. Study completionNov 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02984956
Sponsor's protocol ID
ERZINCAN UNIVERSITY 4
Status last verified
Dec 2016
First submitted
4 Dec 2016
Last updated
8 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Kumar A, Anel R, Bunnell E, Habet K, Zanotti S, Marshall S, Neumann A, Ali A, Cheang M, Kavinsky C, Parrillo JE. Pulmonary artery occlusion pressure and central venous pressure fail to predict ventricular filling volume, cardiac performance, or the response to volume infusion in normal subjects. Crit Care Med. 2004 Mar;32(3):691-9. doi: 10.1097/01.ccm.0000114996.68110.c9.

    PubMed 15090949

  • Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.

    PubMed 17080001

  • Preisman S, Kogan S, Berkenstadt H, Perel A. Predicting fluid responsiveness in patients undergoing cardiac surgery: functional haemodynamic parameters including the Respiratory Systolic Variation Test and static preload indicators. Br J Anaesth. 2005 Dec;95(6):746-55. doi: 10.1093/bja/aei262.

    PubMed 16286349

  • Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.

    PubMed 18522935

  • Derichard A, Robin E, Tavernier B, Costecalde M, Fleyfel M, Onimus J, Lebuffe G, Chambon JP, Vallet B. Automated pulse pressure and stroke volume variations from radial artery: evaluation during major abdominal surgery. Br J Anaesth. 2009 Nov;103(5):678-84. doi: 10.1093/bja/aep267. Epub 2009 Sep 29.

    PubMed 19797246

  • Solus-Biguenet H, Fleyfel M, Tavernier B, Kipnis E, Onimus J, Robin E, Lebuffe G, Decoene C, Pruvot FR, Vallet B. Non-invasive prediction of fluid responsiveness during major hepatic surgery. Br J Anaesth. 2006 Dec;97(6):808-16. doi: 10.1093/bja/ael250. Epub 2006 Sep 16.

    PubMed 16980709

  • Cannesson M, Delannoy B, Morand A, Rosamel P, Attof Y, Bastien O, Lehot JJ. Does the Pleth variability index indicate the respiratory-induced variation in the plethysmogram and arterial pressure waveforms? Anesth Analg. 2008 Apr;106(4):1189-94, table of contents. doi: 10.1213/ane.0b013e318167ab1f.

    PubMed 18349191

  • Zimmermann M, Feibicke T, Keyl C, Prasser C, Moritz S, Graf BM, Wiesenack C. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. doi: 10.1097/EJA.0b013e328335fbd1.

    PubMed 20035228

  • Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.

    PubMed 20705785

  • Desebbe O, Boucau C, Farhat F, Bastien O, Lehot JJ, Cannesson M. The ability of pleth variability index to predict the hemodynamic effects of positive end-expiratory pressure in mechanically ventilated patients under general anesthesia. Anesth Analg. 2010 Mar 1;110(3):792-8. doi: 10.1213/ANE.0b013e3181cd6d06.

    PubMed 20185658

Questions about this trial

What is this clinical trial studying?

An observational study of Hypotension and Pleth Variability Index, run by Erzincan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detecting pleth variability index-hypotension relationship (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02984956, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.

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Pleth Variability Index and Hypotension (NCT02984956) | AzTrials